**16. ICSS study**

The incidence of stroke, death, or procedural myocardial infarction was 8.5% in the stenting group compared with 5.2% in the endarterectomy group (72 vs. 44 events; HR 1.69, 1.16-2.45, p=0.006), Risks of any stroke (65 vs. 35 events; HR 1.92, 1.27-2.89) and all-cause death (19 vs. seven events; HR 2.76, 1.16-6.56) were higher in the stenting group than in the endarterectomy group. Three procedural myocardial infarctions were recorded in the stenting group, all of which were fatal, compared with four, all non-fatal, in the endarterectomy group.[26]

At 1 month, there were changes on fluid-attenuated inversion recovery sequences in 28 (33%) of 86 patients in the stenting group and six (8%) of 75 in the endarterectomy group (adjusted OR 5 93, 95% CI 2 25–15 62; p=0 0003). In patients treated at a center with a policy of using cerebral protection devices, 37 (73%) of 51 in the stenting group and eight (17%) of 46 in the endarterectomy group had at least one new DWI lesion on post-treatment scans (adjusted OR 12 20, 95% CI 4 53–32 84), whereas in those treated at a center with a policy of unprotected stenting, 25 (34%) of 73 patients in the stenting group and ten (16%) of 61 in the endarterectomy group had new lesions on DWI (adjusted OR 2 70, 1 16–6 24; interaction p=0 019).[27]

These discordant results may be explained by the fact that the EVA-3S and SPACE studies differ from ours in numerous ways, including in the selection criteria (e.g., the EVA-3S and SPACE trials included neither patients with a high surgical risk nor asymptomatic patients), the rate of use of specific emboli-protection devices (in 92% of cases in the EVA-3S trial and 27% in the SPACE trial), and the experience level of the physician who placed the stent (in the EVA-3S trial, stents could be placed by physicians who had performed as few as five previous carotid-stent procedures or, if working under the direction of a tutor, no previous procedures).[18]

The results of the previous studies were a major setback for stenting. They created a general belief among practicing physicians and neurologists that carotid artery stenting has only a limited role in the prevention of stroke. This set the stage ready for a more comprehensive larger trial trying to reach the truth.
